The United Arab Emirates (UAE) is a thriving market for health and dietary supplements, driven by a health-conscious population and a growing focus on wellness. However, registering food supplements in the UAE, particularly with the Dubai Municipality (DM) and the Ministry of Health and Prevention (MOHAP), comes with its share of challenges. Strict regulations ensure consumer safety, but they can pose hurdles for businesses. In this blog, we explore the top five challenges in food supplement registration in the UAE and provide actionable solutions to overcome them.
1. Navigating Complex Regulatory Requirements
The UAE has stringent regulations to ensure the safety and efficacy of food supplements. These include compliance with Gulf Standardization Organization (GSO) standards, such as GSO 2571/2021 for health supplements and UAE.S GSO 2333:2019 for permitted health and nutrition claims. Misunderstanding or failing to meet these requirements can lead to application rejections or delays.
How to Overcome It:
- Partner with Experts: Engage regulatory consultants with experience in UAE food supplement registration, such as those from Freyr or Artixio, to ensure compliance with DM and MOHAP guidelines.
- Conduct Thorough Research: Review GSO standards and MOHAP regulations to understand specific requirements for ingredients, labeling, and claims.
- Pre-Submission Checklist: Create a checklist of all required documents, including a valid trade license, Good Manufacturing Practice (GMP) certificate, and Free Sale Certificate (FSC), to streamline the process.
2. Stringent Documentation Requirements
The registration process demands extensive documentation, including product composition details, ingredient reports, Certificates of Analysis (CoA), and Halal certificates. Incomplete or incorrect documentation is a common reason for application rejection.
How to Overcome It:
- Prepare Comprehensive Dossiers: Ensure all documents, such as the FSC, GMP certificate, and high-resolution product labels, are complete and accurate.
- Use Professional Services: Leverage firms like The Infinite Service or Commitbiz to review and compile documentation, reducing the risk of errors.
- Verify Halal Compliance: For products targeting the UAE’s Muslim population, obtain a Halal certificate from a certified authority to meet cultural and regulatory expectations.
3. Labeling and Claims Compliance
UAE regulations require food supplement labels to include specific information in both Arabic and English, such as ingredient lists, nutritional facts, and disclaimers that the product is not a substitute for a varied diet. Misleading or unsubstantiated claims can lead to product bans.
How to Overcome It:
- Conduct Label Assessments: Work with regulatory experts to ensure labels meet UAE.S GSO 9:2022 standards, including clear indications of “Food Supplement” and nutrient quantities.
- Substantiate Claims: Provide scientific evidence for health or structure/function claims, ensuring they meet GSO CAC/GL 55:2015 guidelines. For example, nutrient claims must align with Recommended Dietary Allowance (RDA) values.
- Bilingual Labeling: Ensure labels are bilingual (Arabic and English) and comply with font, format, and shelf-life requirements (e.g., at least 50% of shelf life remaining upon import).
4. Ingredient Restrictions and Classification
Certain ingredients permitted in other countries may be banned or restricted in the UAE, and misclassification of a product as a health supplement versus a medicine can delay approval. The Dubai Municipality may also require laboratory testing for products with critical ingredients.
How to Overcome It:
- Perform Ingredient Assessments: Conduct a thorough review of ingredients against the DM’s list of banned substances to ensure compliance.
- Seek Pre-Classification: Obtain official product classification from MOHAP before submission to avoid misclassification issues.
- Engage Testing Labs: If required, submit products for laboratory testing to verify safety and compliance with UAE standards.
5. Time-Consuming Approval Process
The registration process can take 12 working days or longer if additional information or testing is required. Delays can disrupt market entry plans and increase costs.
How to Overcome It:
- Streamline Submissions: Use the Montaji portal for online applications and ensure all documents are uploaded correctly to avoid delays.
- Proactive Follow-Ups: Monitor application status through the DM or MOHAP portals and respond promptly to requests for additional information.
- Leverage Local Partners: Work with a UAE-based company holding a valid trade license to act as a local representative, facilitating communication with authorities.
Registering food supplements in the UAE is a complex but manageable process with the right approach. By understanding regulatory requirements, preparing thorough documentation, ensuring compliant labeling, verifying ingredients, and streamlining submissions, businesses can overcome these challenges and successfully enter the UAE market. Partnering with experienced consultants and staying updated on regulations will ensure a smooth registration process, allowing you to tap into the UAE’s booming health supplement market.
